TPLC - Total Product Life Cycle

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Device	folders and injectors, intraocular lens (iol)
Product Code	MSS
Regulation Number	886.4300
Device Class	1

Premarket Reviews
Manufacturer	Decision
ALCON LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
AST PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	2
BAUSCH & LOMB INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
BAUSCH & LOMB, INC
	SUBSTANTIALLY EQUIVALENT	1
JOHNSON & JOHNSON SURGICAL VISION, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDICEL AG
	SUBSTANTIALLY EQUIVALENT	1
RXSIGHT, INC.
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Damaged by Another Device	488	488
Device Contamination with Chemical or Other Material	388	388
Adverse Event Without Identified Device or Use Problem	252	252
Crack	208	208
Material Split, Cut or Torn	147	147
Scratched Material	144	144
Break	100	100
Contamination /Decontamination Problem	73	73
Defective Device	73	73
Failure to Eject	71	71
Material Twisted/Bent	43	43
Physical Resistance/Sticking	38	38
Contamination	33	33
Defective Component	29	29
No Apparent Adverse Event	23	23
Material Fragmentation	22	22
Use of Device Problem	19	19
Insufficient Information	19	19
Appropriate Term/Code Not Available	17	17
Failure to Advance	17	17
Particulates	16	16
Fracture	13	13
Difficult to Advance	12	12
Material Separation	10	10
Mechanical Problem	10	10
Activation, Positioning or Separation Problem	9	9
Difficult to Remove	8	8
Burst Container or Vessel	8	8
Device Handling Problem	7	7
Inaccurate Delivery	6	6
Ejection Problem	6	6
Unintended Ejection	6	6
Mechanical Jam	5	5
Material Deformation	5	5
Material Rupture	5	5
Improper or Incorrect Procedure or Method	4	4
Device Difficult to Setup or Prepare	4	4
Entrapment of Device	4	4
Deformation Due to Compressive Stress	3	3
Detachment of Device or Device Component	3	3
Product Quality Problem	3	3
Difficult to Insert	3	3
Off-Label Use	3	3
Noise, Audible	2	2
Fitting Problem	2	2
Material Protrusion/Extrusion	2	2
Device Markings/Labelling Problem	2	2
Failure to Deliver	2	2
Failure to Fold	2	2
Therapeutic or Diagnostic Output Failure	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	791	791
Insufficient Information	607	607
No Known Impact Or Consequence To Patient	286	286
No Consequences Or Impact To Patient	106	106
Capsular Bag Tear	63	63
No Code Available	55	55
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	43	43
Eye Injury	38	38
Foreign Body In Patient	30	30
Vitrectomy	26	26
Visual Impairment	18	18
Corneal Edema	14	14
Visual Disturbances	10	10
Failure of Implant	8	8
Endophthalmitis	8	8
Foreign Body Sensation in Eye	7	7
Vitreous Loss	7	7
Blurred Vision	6	6
Toxic Anterior Segment Syndrome (TASS)	6	6
Loss of Vision	5	5
No Information	5	5
Inflammation	5	5
No Patient Involvement	5	5
Device Embedded In Tissue or Plaque	4	4
Eye Pain	4	4
Vitreous Floaters	4	4
Swelling/ Edema	4	4
Corneal Abrasion	4	4
Iritis	4	4
Edema	3	3
Unspecified Eye / Vision Problem	3	3
Hypopyon	3	3
Hemorrhage/Bleeding	3	3
Keratitis	2	2
Halo	2	2
Intraocular Pressure Increased	2	2
Fibrosis	2	2
Wound Dehiscence	2	2
Uveitis	2	2
Zonular Dehiscence	1	1
Abrasion	1	1
Injury	1	1
Corneal Touch	1	1
Conjunctivitis	1	1
Discomfort	1	1
Corneal Decompensation	1	1
Pain	1	1
Failure to Anastomose	1	1
Red Eye(s)	1	1
Macular Edema	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Rayner Intraocular Lenses Limited	II	Apr-21-2020